Integra NeuroSciences Launches NeuroSensor Cerebral Blood Flow and Intracranial Pressure System
PLAINSBORO, N.J., Oct. 15, 2004 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it plans to market and sell the NeuroSensor Cerebral Blood Flow and Intracranial Pressure System (NeuroSensor), a neuro-monitoring system used to measure both cerebral blood flow (CBF) and intracranial pressure (ICP) on brain injured patients. Integra NeuroSciences has received 510K clearance from the United States Food and Drug Administration to market the NeuroSensor in the United States. Integra, which is featuring the NeuroSensor at the 2004 Congress of Neurological Surgeons (CNS) Annual Meeting in San Francisco, California next week, plans to sell this product in the United States through its Integra NeuroSciences™ sales force.
The NeuroSensor is an easy to use system that allows clinicians to obtain simultaneous measurements of the patient's CBF and ICP through the use of a single catheter inserted through a low-profile bolt. The system provides relevant measurements for the surgeon on a real-time basis, allowing for continuous qualitative monitoring of CBF in patients at risk of cerebral ischemia, and the direct monitoring of ICP in intraparenchymal applications following injury or neurosurgical procedures. The NeuroSensor measures CBF using laser doppler flowmetry technology and ICP using a micro-electro mechanical system (MEMS).
In neurosurgical intensive care units today, the most common means of direct physiological monitoring is the measurement of ICP. The NeuroSensor was developed to provide clinicians with a means to measure CBF, a more sensitive indicator of cerebral perfusion, while also measuring ICP. ICP monitoring alone shows the end result of the loss of autoregulation and not the onset. By detecting the conditions that lead to increased ICP, such as certain changes in CBF, it is believed that further injury to the brain can be prevented or limited.
"The NeuroSensor Cerebral Blood Flow and Intracranial Pressure System is an important addition to Integra's ICU and critical care product line," said Deborah Leonetti, Integra's Senior Vice President of Marketing. "Our goal is to provide on-line and real-time multi-modality monitoring as the standard of care. Only Integra can provide surgeons with the means to monitor many of these critical physiological parameters. We are very proud to offer this cutting-edge technology for the treatment and care of patients with neurotrauma and cerebrovascular disease."
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neuro-trauma and neurosurgery, plastic and reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. We have approximately 1,200 employees. Please visit our website at (http://www.Integra-LS.com).
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the use of our NeuroSensor. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to use the NeuroSensor may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors That May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2003 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.p> CONTACT:
Integra LifeSciences Holdings Corporation
John B. Henneman, III
Executive Vice President
Chief Administrative Officer
Director of Corporate Development and Investor Relations